Manager, Quality Assurance & Regulatory Affairs - Englewood, CO
Getinge
- Denver, CO
- $140,000-155,100 per year
- Permanent
- Full-time
Is a Management Representative for quality system, responsible for maintaining compliant quality system, implementing new and updated product related regulatory requirements of applicable markets and jurisdictions, ensuring full audit readiness of the organization and leading a quality team. This role requires strong leadership, technical expertise in quality assurance and regulatory affairs, and the ability to collaborate effectively with cross-functional teams.Job Functions:
- Is a Management Representative according to ISO 13485 requirements
- Lead projects that impact the Quality Management System
- Identify and track actions and milestones arising from the Corrective and Preventive Action process, Audit findings, or
- Report on progress against schedules, milestones, and project goals
- Respond to internal and external audit findings and assist in planning, corrections and prevention as needed.
- Develop, administer, and maintain the quality management system (QMS), including the Quality Manual, QMS
- Manage all aspects of audits by external agencies:
- Responsible for ensuring compliance of local audit support procedures to external regulations and standards and corporate procedures
- Responsible for ensuring record retention policies related to audit records are followed
- Complaint handling/Vigilance responsibility - maintenance of vigilance system in compliance with relevant regulations,
- Ship holds, recalls, field actions management, and blocking of non-conforming materials and products
- Maintenance, review, and implementation of standards and regulations affecting the product and the QMS
- Manage the corrective & preventive action system (CAPA)
- Provide regulatory guidance on business matters for the US and world markets, liaise with regulatory bodies, ensure
- Responsible for continuous improvement, internal audits, and third-party audits for certifications and investigations,
- Product release - ensuring product release in accordance with quality and regulatory requirements
- Supplier approval and management of supplier auditing system
- In-depth knowledge of ISO 13485 and FDA 21CFR820 requirements. Knowledge of EU MDR beneficial
- Analytical mindset with strong problem solving skills
- High level of attention to detail and accuracy
- Strong computer skills, including MS Office applications (Word/Excel) and Microsoft Project are required
- Proficiency in relevant software applications (e.g., document management systems, quality management systems) is
- Demonstrated leadership experience with the ability to lead and develop a team, drive accountability, and foster a
- Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams,
- Bachelor's Degree or equivalent work experience
- A minimum of four years related Quality Management experience in an FDA regulated environment
- Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
- Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
- Must have the education and experience to understand and comply with U.S. and Worldwide medical device
- Attend all required Quality & Compliance training at the specified interval.
- Adopt the “Beyond Compliance Quality Culture” in the work environment; always meet and exceed requirements.
- Daily use of computer/laptop and related accessories in an office environment
- Occasional work in controlled environment
- Ensures environmental consciousness and safe practices are exhibited in decisions.
- Use of computer and telephone equipment and other related office accessories/devices to complete assignments.
- May work extended hours during peak business cycles.
- Hearing necessary to receive and reply to outside contacts and employees. Ability to speak clearly in order to
- Some bending, stooping, reaching and lifting (up to 15 pounds) is required. Willingness to frequently move to various
Responsible for the development and management of personnel and programs in the Quality and Regulatory department.Disclaimer:
The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.#LI-DV1About usGetinge is on an exciting transformation journey constantly looking for new ways to innovate together with our customers to meet the healthcare challenges of the future. We are committed to diversity, equity and inclusion and to sustainability with a goal to be CO2 neutral by 2025. We believe in giving our employees the flexibility they need and make every effort to foster a learning culture that supports their personal development and creativity. Our passionate people hold our brand promise 'Passion for Life' close to heart.If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application and resume. We hope you will join us on our journey to become the world's most respected and trusted Medtech company.Benefits at Getinge:At Getinge, we offer a comprehensive benefits package, which includes:
- Health, Dental, Vision and Travel insurance benefits
- Retirement Plan with company match
- Personal Flex Time
- Wellness initiative & Health Assistance Resources
- Life Insurance
- Short and Long Term Disability Benefits
- Parental and Caregiver Leave
- Tuition Reimbursement